Minimally-invasive tissue suturing device

ABSTRACT

An apparatus for suturing tissue, comprising: a needle having a beveled opening and housing multiple anchors, wherein each of said anchors comprises an elongated tubular body and a loop connected to said tubular body, and wherein a thread is threaded sequentially through the loops; and a pushrod configured to push each of said anchors towards the opening of said needle, to extract each respective anchor from the opening.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a National Phase of PCT Patent Application No.PCT/IL2017/051234 having International filing date of Nov. 13, 2017,which claims the benefit of priority to U.S. Provisional PatentApplication No. 62/421,319, filed Nov. 13, 2016, and entitled“Minimally-Invasive Tissue Suturing Device”. The contents of the aboveapplications are all incorporated by reference as if fully set forthherein by reference in their entirety.

BACKGROUND

The invention relates to the field of suturing devices.

Suturing remains a common approach for repair of live tissue and is usedfor tissue closure, approximation, ligation and fixation of tissueaccess sites, organs, vessels, fixation of meshes and other implants ordevices and the like. Although largely dependent on the skill of thesurgeon, the results obtained using a suture are highly predictable andreliable.

Alternatives to suturing developed over the years such as staples,fasteners (also known as “tacks”), anchors, and tissue adhesives, havegained varying degrees of acceptance and are used for tissue repair inboth open and minimally invasive procedures. Nonetheless, suturingremains ubiquitous in surgical repair due to availability of a widevariety of suturing kits at relatively low costs and the mechanicaladvantages afforded by suturing.

Thus, suture remains a mainstay of surgical repair however, it is notwithout disadvantages. Placing a number of stitches can be tiring andtime-consuming which can lead to suturing errors that can compromise theintegrity of repair. In addition, manipulation of a suture needle aswell as access to the suturing location can be difficult especially inminimally invasive surgery due to the nature of the minimally invasivesurgery and/or the limited anatomical space around the target tissues,while tying knots with a desired amount of tension requires precisemanipulation of the suture ends further complicating and slowing open,and in particular, minimally-invasive surgeries. In fact, for manyprocedures the time spent suturing may be significantly greater than thetime spent treating the underlying target tissues.

In some ventral and incisional hernia cases, where the defect isrelatively large (for example over a few centimeters), it is commonpractice not to suffice with mesh reinforcement but also to physicallysuture (“close”) the abdominal wall at the site of the defect. Theclosure may be done extracorporeally or intracorporeally. Closure ofsuch defects is known to significantly decrease the reoccurrence of thehernia, relative to reinforcement with just a mesh. For example, Zeichenet al. (2012) showed that recurrence rates were threefold lower whenclosure was done in addition to mesh reinforcement. See Zeichen et al.,“Closure Versus Non-closure of Hernia Defect During Laparoscopic VentralHernia Repair With Mesh”, SAGES Abstracts, 2012.

FIGS. 1A, 1B, and 1C show three stages of hernia defect closure withmesh reinforcement, in accordance with prior art. FIG. 1A illustratesthe large hernia defect in a cross-sectional view. FIG. 1B shows a topview of the defect being sutured in extracorporeal approach, after amesh has already been affixed. FIG. 1C shows the final state, after thesuture has been tensioned and knotted, and the mesh deployed and affixedunderneath the fascia.

The foregoing examples of the related art and limitations relatedtherewith are intended to be illustrative and not exclusive. Otherlimitations of the related art will become apparent to those of skill inthe art upon a reading of the specification and a study of the figures.

SUMMARY

The following embodiments and aspects thereof are described andillustrated in conjunction with systems, tools and methods which aremeant to be exemplary and illustrative, not limiting in scope.

Some embodiments are directed to an apparatus for suturing tissue,comprising: an elongated shaft; a hollow needle disposed inside saidelongated shaft, said needle having: an elongated slit which opens to adistal end of said needle, and an aperture disposed at a distal area ofsaid needle; a handle disposed at a proximal end of said elongatedshaft; multiple anchors disposed in a single file inside said needle,along the length of said needle, wherein each of said multiple anchorscomprises: an elongated tubular body, a loop connected to said tubularbody and exiting said needle through said elongated slit to a spacebetween said needle and an inner wall of said elongated shaft, a finemerging outwardly from said elongated tubular body, wherein a free endof said fin points toward the proximal end of said elongated shaft, andwherein the fin of the most distal anchor in the single file protrudesfrom said needle through said aperture; a thread disposed along thelength of said elongated shaft, in the space between said needle andsaid inner wall of said elongated shaft, and threaded sequentiallythrough said loops of said anchors; and a pushrod disposed in the spacebetween said needle and said inner wall of said elongated shaft, whereinsaid pushrod is triggerable by said handle to push the fin of the mostdistal anchor in the single file, thereby to eject the most distalanchor in the single file from a distal opening of said needle.

In some embodiments, said loop is a cord emerging from an outer wall ofsaid elongated tubular body, and terminating with a ring.

In some embodiments, said loop is a rigid wire having a proximal curlsecured to said anchor, a straight section, and a distal curl throughwhich said thread is threaded.

In some embodiments, the apparatus further comprises a push tubedisposed inside the elongated shaft and over the needle, wherein thepushrod is attached to a distal end of said push tube, and wherein thetriggering of the pushrod is by pushing said push tube distally.

In some embodiments, said handle comprises a trigger connected to aproximal end of said push tube.

In some embodiments, said pushrod is flexible and bends when passingthrough said aperture to push said fin.

In some embodiments, said fin emerges from said elongated tubular bodyopposite said loop.

In some embodiments, said handle is configured to allow said elongatedshaft to retract into said handle while maintaining said needlestationary, so that a distal area of said needle is exposed andpenetrates tissue.

In some embodiments, said handle comprises a shaft blocking lever thatis movable between a position that blocks backwards movement of saidshaft and a position that allows backwards movement of said shaft.

In some embodiments, said handle comprises a spool of thread.

In some embodiments, said handle comprises a trigger that is connectedto said pushrod.

In some embodiments, the apparatus further comprises a push tubedisposed inside the elongated shaft and over the needle, wherein thepushrod is attached to a distal end of said push tube, and wherein thetriggering of the pushrod is by pushing said push tube distally; and atrigger comprised in said handle, wherein said trigger is connected tosaid push tube, such that depressing said trigger pushes said push tubedistally.

Some embodiments are directed to an apparatus for suturing tissue,comprising: a needle having a beveled opening and housing multipleanchors, wherein each of said anchors comprises an elongated tubularbody and a loop connected to said tubular body, and wherein a thread isthreaded sequentially through the loops; and a pushrod configured topush each of said anchors towards the opening of said needle, to extracteach respective anchor from the opening.

In some embodiments, each of said anchors further comprises a finemerging outwardly from said elongated tubular body, wherein saidpushrod is configured to push each of said fins towards the opening ofsaid needle.

In some embodiments, said pushrod is sized to push each of said finsuntil the respective anchor completely exits the opening of said needle.

In some embodiments, the apparatus further comprises an elongated shaft,wherein said needle is disposed inside said elongated shaft.

In some embodiments, the apparatus further comprises a handle disposedat a proximal end of said elongated shaft.

In some embodiments, the apparatus further comprises a pushrod disposedin a space between said needle and said inner wall of said elongatedshaft, wherein said pushrod is triggerable by said handle to push thefin of the most distal anchor in the single file, thereby to eject themost distal anchor in the single file from a distal opening of saidneedle.

In some embodiments, the apparatus further comprises a push tubedisposed inside the elongated shaft and over the needle, wherein thepushrod is attached to a distal end of said push tube, and wherein thetriggering of the pushrod is by pushing said push tube distally.

In some embodiments, said handle comprises a trigger that is connectedto a proximal end of said push tube.

In some embodiments, said needle has an aperture disposed at a distalarea of said needle, said pushrod is flexible and bends when passingthrough said aperture to push said fin, and the fin of the most distalanchor in the single file protrudes from said needle through saidaperture.

In some embodiments, said needle has an elongated slit which opens to adistal end of said needle.

In some embodiments, said loop exits said needle through said elongatedslit to a space between said needle and an inner wall of said elongatedshaft.

In some embodiments, said fin emerges from said elongated tubular bodyopposite said loop.

In some embodiments, said handle is configured to allow said elongatedshaft to retract into said handle while maintaining said needlestationary, so that a distal area of said needle is exposed andpenetrates tissue.

In some embodiments, said handle comprises a shaft blocking lever thatis movable between a position that blocks backwards movement of saidshaft and a position that allows backwards movement of said shaft.

In some embodiments, said handle comprises a spool of thread.

Some embodiments are directed to a method for closing an opening in atissue, comprising: sequentially deploying anchors in the tissue, aroundthe opening, wherein: (a) each of the anchors comprises an elongatedtubular body, a loop connected to said tubular body, and a fin emergingoutwardly from said elongated tubular body opposite said loop, (b) athread is threaded through the loops of the anchors, and (c) the loopsare partially exposed from the tissue, and the thread is completelyexposed from the tissue; and pulling the thread, thereby approximatingthe loops, approximating the anchors, and closing the opening in thetissue.

In addition to the exemplary aspects and embodiments described above,further aspects and embodiments will become apparent by reference to thefigures and by study of the following detailed description.

BRIEF DESCRIPTION OF THE FIGURES

Exemplary embodiments are illustrated in referenced figures. Dimensionsof components and features shown in the figures are generally chosen forconvenience and clarity of presentation and are not necessarily shown toscale. The figures are listed below.

FIGS. 1A, 1B, and 1C show three stages of hernia defect closure withmesh reinforcement, in accordance with prior art;

FIG. 2A is a side view of an apparatus for suturing tissue, inaccordance with an embodiment;

FIGS. 2B, 2C and 2D are semi-transparent views of the apparatus forsuturing tissue, in accordance with an embodiment;

FIG. 3A is a cross-sectional view of a distal portion of a shaft of theapparatus, in accordance with an embodiment;

FIG. 3B is a distal-to-proximal view of the distal portion of the shaft,in accordance with an embodiment;

FIG. 3C is a semi-transparent perspective view of the distal portion ofthe shaft, in accordance with an embodiment;

FIGS. 4A, 4B, and 4C are a cross-section view and two side views,respectively, of the distal portion of the shaft during deployment of ananchor, in accordance with an embodiment;

FIG. 5 is a cross-sectional view of the distal portion of the shaftafter the deployment of the anchor, in accordance with an embodiment;

FIG. 6A is a cross-sectional illustration of an abdominal wall withthree anchors disposed therein, in accordance with an embodiment;

FIG. 6B is a cross-sectional illustration of the abdominal wall after athread has brought the three anchors closer together to close a defect,in accordance with an embodiment;

FIG. 7 is a photograph of an experimental anchor;

FIGS. 8A-8E are photographs of five stages of an experiment performed bythe inventors;

FIGS. 9A-9B are perspective view of a needle of the apparatus, inaccordance with an embodiment;

FIG. 10A is a perspective view of an anchor, in accordance with anembodiment;

FIGS. 10B and 10C are perspective views of another anchor, in accordancewith an embodiment;

FIGS. 10D, 10E, 10F, and 10G are perspective views of a further anchor,in accordance with an embodiment;

FIG. 10H is a perspective view of a further anchor, in accordance withan embodiment;

FIG. 11A is a perspective view of a unidirectional locking anchor, inaccordance with an embodiment;

FIG. 11B is a perspective view of a bidirectional locking anchor, inaccordance with an embodiment;

FIGS. 12A and 12B illustrate defect closure with a bidirectional locker,in accordance with an embodiment;

FIGS. 13A and 13B illustrate a different defect closure with abidirectional locker, in accordance with an embodiment;

FIGS. 14A, 14B, and 14C illustrate different suturing patterns, inaccordance with embodiments;

FIG. 15 is a cross-sectional view of a multi-lumen shaft, in accordancewith an embodiment; and

FIG. 16 is an illustration of nerve or blood vessel entrapment, inaccordance with an embodiment.

DETAILED DESCRIPTION

Disclosed herein is an apparatus for suturing tissue, and a method forsuturing tissue using the apparatus. The apparatus may be used, forexample, for minimally-invasive hernia defect closure during alaparoscopic ventral hernia repair (LVHR) procedure.

Alternatively, the apparatus may be used for a different suturing task,such as, but not limited to, closing a laparotomy incision or performingother intracorporeal approximation or fixation. For reasons ofsimplicity, the disclosure describes the apparatus and method inrelation to closure of a hernia defect, but those of skill in the artwill recognize that these descriptions may apply, mutatis mutandis, toother suturing tasks.

Advantageously, the apparatus deploys multiple anchors that arestructured in a way that: (a) prevents or mitigates damage tosurrounding tissue, (b) allows the tissue to be closed by a convenientand simple pulling of a thread, after the anchors have been deployedsatisfactorily, (c) enables strong fixation while not protruding outsidethe body, thus reducing risk of infection, (d) reduces tension on thesutured tissue (compared with regular, manual suturing) and thus reducesthe risk of tissue trauma and thread ‘cheese cuts’, (e) does not form aloop that encapsulates tissue, and thus decreases the risk for nerveentrapment and reduction of blood flow to the encapsulated tissue, (f)enforces standardized suturing thus reduces the variability betweensurgeons of different skill levels, (g) reduces hernia recurrence rateswhile simplifying the procedure, (h) divides tension between allanchors, (i) when tensioning the thread, reduces friction of the threadwith the anchor, by concentrating the friction of the thread on a smoothring or loop, and (j) reduced the amount of artificial material thatremains exposed from the tissue after the procedure, thus reducingadhesion risks. Namely, the apparatus facilitates the convenientformation of a continuous suture.

Reference is now made to FIGS. 2A and 2B, which show a side view and asemi-transparent view, respectively, of an apparatus 100 for suturingtissue, in accordance with an embodiment. Apparatus 100 generallyincludes a handle 102 and an elongated shaft 104. Only a proximalportion of shaft 104 is shown in FIG. 2B. Those of skill in the art willrecognize that the apparatus may be readily adapted for use by asurgical robot; for example, the various physical actuators included inthe handle may be structured in a way that allows electromechanicalactuators of the robot to manipulate them.

Reference is also made to FIGS. 3-5, which show a distal portion ofshaft 104 in various stages of the operation of apparatus 100. Shaft 104may have a length of, for example, 50-700 millimeters (mm), wherein partof this length is inside handle 102. Shaft 104 may have an externaldiameter of, for example, 2 to 10 mm, and a wall thickness of, forexample, 0.2 to 0.6 mm. Shaft 104 may have a uniform or a variablediameter along its length.

Handle 102 may include one or more user-operable actuators, such as, butnot limited to, a trigger 106, a cam shaft 162, and a spool 120 a. Theseuser-operable actuators may serve to activate an anchor advancementmechanism disposed in handle 102 and/or in shaft 104, whose role is todeploy multiple anchors from apparatus 100 into tissue.

Shaft 104 may be an elongated tube, either (a) rigid (for use inlaparoscopic procedures), (b) rigid with a bended angle or flexible (foruse in either laparoscopic or endoscopic procedures), or (c) rigid withcontrollable articulation capabilities—either at one or moremanipulatable joints, or along entire segment(s) of the shaft. Shaft 104may be made, for example, of plastic and/or metal.

A hollow needle 108 having a sharp (optionally beveled) edge 110 may bedisposed inside shaft 104 longitudinally. Needle 108 may have the samelength as shaft 104 or a different length. Needle 108 may have anexternal diameter of, for example, 0.8 to 5 mm, and a wall thickness of,for example, 0.2 to 0.6 mm. Shaft 104 may have a uniform or a variablediameter along its length. Needle 108 may be made of stainless steel orany other suitable material. There may be one needle inside the shaft ormultiple needles (shown on page 1 of Appendix A). In the case ofmultiple needles, each may be used to deploy a single anchor, or,alternatively, each may be used to deploy multiple anchors.

Needle 108 optionally has a longitudinal slit 117 which extends fromedge 110 to either a proximal edge (not shown) of the needle, or lessthan that. Slit 117 is shown as continuous slit, but in otherembodiments it may be divided into multiple slits along the length ofneedle 108. Slit 117 may be, for example, 0.1 to 1 mm wide. Its widthmay be uniform of variable along its length.

Optionally, needle 108 has one or more apertures 124 in its wall, thatare optionally disposed on a side of the wall opposite slit 117. Ifmultiple apertures are present, such as a frontal aperture 124 a and adorsal aperture 124 b, they may be equidistantly or non-equidistantlydisposed.

FIGS. 9A-9B are top and bottom perspective views of needle 108, in whichslit 117 and aperture 124 are more clearly visible.

Optionally, needle 108 has one or more anchor stoppers 128, embodied asresilient protrusions from an inner wall of the needle into the lumen ofthe needle—thus decreasing the inner diameter of the needle at thatlocation. Stoppers 128 may normally protrude into the lumen of needle108, but may be pushed completely or partially out of the lumen when ananchor (further discussed below) applies on it a sufficient amount offorce. Stopper 128 may be constructed such that it can resist apredetermined amount of force.

Multiple anchors 112 may be disposed in a single file inside needle 108.Each of anchors 112 may have an elongated tubular body made of a rigidmaterial, such as stainless steel, nitinol (nickel-titanium alloy),and/or plastic (permanent, such as polyether ether ketone, orbioabsorbable, such as poly(lactic-co-glycolic acid)). The tubular bodymay have a diameter of, for example, 0.5-3 millimeters (mm), a wallthickness of, for example, 0.05 to 0.4 mm, and a length of, for example,2-15 mm. Alternatively, the anchor may have a solid cylindrical body, orhave a different shape which is substantially elongated, such as arectangular box or the like.

A loop may be connected to, attached to, or integrally formed with thetubular body of anchor 112, such as a loop of wire or a differentmaterial. For example, the loop may be embodied as a cord 114 thatemerges from the outer wall of each anchor 112. Cord 114 may be asurgical thread (sometimes referred to as a “surgical suture”), or aflexible or rigid rod (straight, curved, spring-coiled, etc.) made of asuitable material such as stainless steel, nitinol, plastic, etc. Cord114 is optionally also tensile, with such tensile strength allowing upto approximately 20% to 100% elongation without plastic deformation.Such tensile properties of cord 114 may further reduce tension from thetissue in which anchor 112 is implanted, when the thread is pulled andtensioned. Cord 114 may have a circular profile or a non-circularprofile. Cord 114 may be attached to, connected to, or integrally formedwith anchor 112. Cord 114 may have a diameter of, for example, 0.1-2 mm,which may be uniform of variable along its length. Optionally, cord 114is doubled over itself, such that there are in fact two cord segmentsextending between the outer wall of anchor 112 and a ring, which isdescribed below. Cord 114 may be attached to, connected to, orintegrally formed with anchor 112.

Cord 114 may terminate with a ring 116, or, alternatively, with asimilarly-functional closed structure (not shown) that allows a threadto pass therethrough. Optionally, ring 116 is smooth and lacks any sharpedges, thus preventing or mitigating damage to the thread from frictionwith the ring. Ring 116 may be made of a rigid or flexible material,such as stainless steel, nitinol, or plastic. Ring 116 may be attachedto, connected to, or integrally formed with cord 114. Cord 114 may berotatable around its longitudinal axis, to prevent thread loops (athread 118 is discussed below) over ring 116.

Alternatively, as shown in FIG. 10A, anchor 112 may have a loop ofsuture 114 a, optionally with a protective cover 114 b at its middle, tolower friction with thread 118.

Further optionally, as shown in FIGS. 10B and 10C, anchor 112 may have arigid wire 114 c as its loop. Wire 114 c may be straight along most ofits length, except in its (a) proximal area 114 d, where it curls toform an arc of at least 250 degrees, the arc encircling a bridge 112 abetween two opposing elongated slits 112 b in the tubular body of theanchors, (b) distal area 114 e, where it curls helically or to about 360degrees or more, such that the thread can pass inside this curl withoutescaping. If using a thicker thread, the curl may form an arc of lessthan 360 degrees, such as between 270 and 350 degrees. When anchor 112is inside the needle, wire 114 c may assume the position shown in FIG.10B—substantially parallel to the longitudinal axis of anchor 112. Whenanchor 112 is deployed in tissue and the thread is tensioned, wire 114 cmay assume the position shown in FIG. 10C—substantially perpendicular tothe longitudinal axis of anchor 112. Rigid wire 113 c is optionally madeof stainless steel, and has a diameter of between 0.2 to 1 mm, or morespecifically 0.3 to 0.7 mm. The curl at the distal area 114 e of rigidwire 113 c is optionally tilted away from the anchor, so as to allowfree pass of the thread through the loops of the anchors when the cordlies substantially parallel to the anchor inside the shaft. The tiltingis optionally of an angle between 10 and 45 degrees, but could be to agreater or lesser angle.

FIGS. 10D-10G show a variant of the anchor of FIGS. 10B-10C, in whichthe rigid wire has a different configuration in its proximal and distalareas. In the proximal area, the wire has a closed or a nearly closedarc, namely—the distal end of the wire contacts or almost contacts theouter surface of the straight section of the wire. In the distal area,the wire forms a non-helical loop that is closes or nearly closed. FIGS.10D-10E show the anchor with its wire positioned substantially parallelto the anchor, which is the posture the anchor assumes when it is insidethe needle. 10F-10G show the anchor with its wire positionedsubstantially perpendicular to the anchor, which is the posture theanchor assumes when it is within tissue.

FIG. 10H shows a further variant of the previously-shown anchors, inwhich the rigid wire is threaded, in its proximal area, through anaperture in the wall of the anchor. A bulge or a bend (not shown) at theproximal end of the wire prevents it from falling through the aperture.This wire is therefore able to rotate along its length axis, as thearrow shows. This may become useful after the anchor is implanted intissue and the thread tensioned—the thread will rotate the distal loopof the wire to a position where there is the least amount of tension onthe loop. This may lower the probability of disintegration of the wiredue to the tension applied by the thread. In this variant of the anchor,the wire may also be flexible, so that it may resiliently lie flush withthe anchor when inside the needle, and move angularly to the anchorafter being extracted from the needle.

The elongated tubular body of anchor 112 may have a protrusion from itsouter wall, which protrusion is disposed, for example, opposite wherecord 114 emerges from the anchor. An exemplary protrusion is shown inthe figures as a flexible or rigid fin 122, which is a cutout in thewall of anchor 112. When anchor 112 is made of a memory shape material,such as nitinol, fin 122 may be trained to protrude and emerge from thewall of the anchor. A free end 122 a of fin 122 may point towards aproximal end of shaft 104. When anchor 112 is in a position insideneedle 108 where an aperture 124 is present, fin 122 may protrude awayfrom the wall of the anchor, through the aperture. When anchor 112 is ina position inside needle 108 where no aperture is present, fin 122 mayresiliently flatten, to lie flush with the wall of the anchor's tubularbody. As an alternative to a fin which is cut out of the anchor body,another fin (now shown) may be attached or connected to the anchor body.As a further alternative, there may be, for example, multiple fins(e.g., 2-6) that are disposed in different radial locations on or in theanchor body. Fin 122 may, for example, have a sharp free end, a bluntfree end, or a toothed free end, etc.

A thread 118 may be disposed inside shaft 104, along the length of theshaft, and optionally exiting a distal end 104 a of the shaft. Thread118 may be threaded sequentially through rings 116 of anchors 112.Thread 118, at its proximal area, is optionally wound around a spool 120disposed in handle 102. Thread 118 may be disposed inside the shaft soboth ends are proximally located in the handle 102 or outside thehandle, generating a thread loop inside apparatus 100.

Thread 118 is optionally a surgical thread (sometimes referred to as asurgical “suture”), which may be bioabsorbable or non-bioabsorbable.Suitable bioabsorbable materials include, for example, polyglycolicacid, polylactic acid, monocryl, and polydioxanone. Suitablenon-bioabsorbable materials include, for example, nylon, polyester, PVDF(Polyvinylidene fluoride), and polypropylene. Thread 118 may be abraided thread, a monofilament line, or a multifilament line. Thread 118be made of metal or plastic, or of any biocompatible material. Thread118 may be rigid or tensile.

Advantageously, the fact the present thread is not threaded through thebodies of the anchors but rather through the rings or loops that aredistanced from the anchor bodies and are not embedded into tissue,prevents the thread from applying force to the tissue, which may, inextreme cases, even cut the tissue.

Furthermore, when the present thread is tensioned to finally close thetissue, the distancing of the rings from the anchor bodies reducesstress from the anchor bodies and concentrates that stress at the rings,and slightly along the cords.

Further yet, the use of anchors implies that there is a greater surfacearea implanted in the tissue and opposing forces which attempt toextract the anchors from the tissue. If only a suture were used, theonly surface area securing the suturing were that the sutureitself—which is very little.

In addition, the rings (or any other structure through which the threadis threaded) are structured such that they impose as little friction aspossible on the thread. This way, when the thread is tensioned andsecured, and following the entire recovery period, the rubbing of thethread over the rings' surface does not tear or otherwise degrade thethread.

An elongated pushrod 126 may be disposed along the length of shaft 104,and be structured and disposed such that it terminates behind fin 122 ofthe distalmost anchor of the multiple anchors 112, and can be advanceddistally to push the distalmost anchor out of needle 108.

Pushrod 126 may be a rigid rod which optionally has a bend whoseconvexity is pointed towards the inner wall of shaft 104, or a flexiblerod that is capable of bending similarly. Alternatively, the pushrod maybe rigid and straight, and have a downwards protrusion at its distalend, that can be positioned behind the fin of the distalmost anchor(this configuration is not shown). In FIGS. 3-4, the bend is visible inthe section of pushrod 126 which extends from a distal end of thepushrod to approximately the middle of the most proximal anchor 112.This is merely one example; the bend in pushrod 126 may have suchlength, convexity and resiliency to allow it to push a distalmost anchor112, by its fin 122 a, out of needle 108, to a sufficient distance awayfrom edge 110 of the needle such that the anchor tilts inside thetissue, until finally settling in the tissue approximatelyperpendicularly to the length axis of shaft 104. The term “approximatelyperpendicularly” refers to an angle of 30 to 110 degrees, optionally 60to 110 degrees. Optionally, the bend (and optionally other segment(s))of pushrod 126 is resilient, such that when it is not biased by anexternal force (its delimitation between needle 108 and the inner wallof shaft 104), it resiliently moves downwards and furthers the tiltingof the distalmost anchor 112. Pushrod 126 or at least its bend may bemade of an elastic or superelastic metal, nitinol, or an elastomer.

Pushrod 126 may be sized so at to fit through the distalmost aperture124 in needle 108. This way, the distal end of pushrod 126, when pusheddistally, follows fin 122 into the lumen of needle 108, and continues tomove in a downwards direction to facilitate the tilting of thedistalmost anchor 112. Pushrod 126 may be linked to handle 102 via anoptional push tube 126 a, which is disposed inside shaft 104 and overneedle 108. Push tube 126 a may terminate before apertures 124, andpushrod 126 may be attached to an outer surface of the push tube, at thedistal area of the push tube. When handle 102 is utilized to push pushtube 126 a distally, it in turn moves pushrod 126 distally. As analternative to push tube 126 a, the pushrod may extend all the way intothe handle, in the space between the needle and the shaft (thisconfiguration is not shown).

Pushrod 126 may either be the sole element responsible to deploy anchors112 to their final location in the tissue, or be aided by a furtherelement: an optional second elongated pushrod 130 (“advancer rod”) whichmay be embodied as a rod disposed inside needle 108, pushing anchors 112from behind. When apparatus 100 includes advancer rod 130, pushrod 126may serve to push anchor 108 only slightly out of shaft 104 (e.g., untila proximal end of that anchor is 5 to 10 mm away from distal opening 104a of the shaft), and provide the anchor with an initial tilt in adirection opposite the pushrod. In FIGS. 3-5, this direction isdownwards. The initial tilt may be to an angle of, for example, 5 to 30degrees from the original posture of anchor 112 inside needle 108. Then,advancer rod 130 continues to push that anchor 112 distally by pushingthe anchors behind it, until the anchor is positioned sufficiently deepin the tissue (for example, between 5 mm and 30 mm inside the tissue).Due to the initial tilt of anchor 108, the tensioning of thread 118towards the handle, and the continued linear pushing by advancer rod130, anchor 108 continues to tilt as it penetrates deeper into thetissue, until it assumes an approximately perpendicular position.

As briefly discussed above, an anchor advancement mechanism may bedisposed in handle 102 and/or in shaft 104, whose role is to deploymultiple anchors 112 from apparatus 100 into tissue. The term “anchoradvancement mechanism” is meant to refer to those particular parts ofapparatus 100 that: push needle 108 distally, to expose a distal portionthereof out of distal end (also “opening) 104 a of shaft 104, andretract the needle back into the shaft (or, alternatively, retract theshaft while keeping the needle stationary, thereby exposing the distalportion of the needle); and push anchors 112 one at a time, to ejectthen out of distal end 110 of needle 108. The anchor advancementmechanism may be triggerable by handle 102, for example by having auser, such as a surgeon, operate one or more of the user-operableactuators, such as, but not limited to, trigger 106.

FIG. 3B shows a distal-to-proximal view of shaft 104, in which anchor112, fin 122, cord 114, needle 108, push tube 126 a, pushrod 126, andanchor stoppers 128_are visible. Also shown in this figure is a spacer129, which was omitted from FIG. 3A for better clarity of otherelements. Spacer 129 may have the general shape of a disc, whose outerperimeters is in contact with the inner wall of shaft 104. The disc hasmultiple cutouts that accommodate needle 108, the loops, fins 122, andpusher 116. This is better shown in FIG. 3C, which is a perspective viewof a distal area of shaft 104.

In an embodiment, the apparatus lacks a needle, and the anchors aredisposed directly inside the shaft. For example, the shaft may have aninternal structure with spaces (e.g., interconnected lumens) for thesingle file of anchors, the fins, the pushrod that pushes the fins, andthe loops.

In an embodiment, the apparatus lacks a shaft, and the needle is theoutermost tube extending from the handle and inserted into the surgicalsite.

Apparatus 100 may be operated per the following method. This method isdiscussed as a laparoscopic one, but those of skill in the art willrecognize that the same techniques may apply, mutatis mutandis, inmedical procedures in which suturing is done not via laparoscopy.

With reference to FIG. 2B, apparatus 100 may be held by a grip 144 ofhandle 102. Apparatus 100 may be pushed such that shaft 104 isintroduced into a patient's abdomen through a small (e.g., 2-15 mm)incision. Shaft 104 may be either directly inserted through theincision, or indirectly through a trocar or another port. Alternatively,shaft 104 may be inserted through a natural orifice, with or without alater incision made to penetrate from the lumen of the natural orificeinto a desired surgical area.

Optionally, while inserting shaft 104 into the body, a shaft blockinglever 140 may be positioned so as to block the shaft from retractinginto handle 102; a distal side of shaft blocking lever 140 is biaseddownwards using a spring, so that a shaft blocker 140 c assumes aposition being the proximal end of shaft 104, blocking its movement inthe proximal direction. A spring 150 may exert force on shaft 104 topush it in the distal direction. This state of handle 102 is shown inFIG. 2C. This figure shows the same elements of FIG. 2B, but at adifferent state.

Distal opening 104 a of shaft 104 may then be pressed against thetissue, in a location where the surgeon wishes to deploy a first one ofanchors 112. In a hernia defect closure procedure, distal opening 104 aof shaft 104 may be pressed against the peritoneum, a few millimeters upto a few centimeters from the defect.

Referring now to FIG. 2C, the surgeon operates handle 102 to activatethe advancement mechanism, so as to expose a distal portion of needle112 out of distal opening 104 a of shaft 104, such that edge 110 ofneedle 108 penetrates the abdominal wall tissue. This operation ofhandle 102 may first include bringing shaft blocking lever 140 to its upposition, which raises shaft blocker 140 c from behind shaft, allowingthe shaft to retract further into the handle. Shaft 104 is retractedagainst the force of spring 150, so that, if the surgeon releases thepressure of apparatus 100 against the tissue, the shaft will return tocover the exposed end of needle 108, thus preventing potential damage tonearby tissues. Optionally, the penetration depth may be adjusted byrotating a nut 152, which limits how far shaft 104 can retract intohandle 102.

Then, the advancement mechanism pushes pushrod 126 distally, in a forcesufficient to push stopper 128 out of the distalmost anchor's 108 way,and cause that anchor to penetrate the tissue. This involves pressingtrigger 106 (the depressed position of the trigger is not shown in thefigures), which moves a connecting rod 148 distally, which movesdistally a connector 148 a that is attached to push tube 126 a. Pushtube 126 a, in turn, pushes pushrod 126 distally.

When connecting rod 148 is moved distally, it also moves a ratchetedrack 164 distally, by a pin 148 b that pushes forward a front protrusion164 a of the rack. One of the teeth of ratcheted rack 164 engages a base130 a of advancer rod 130, and therefore advances advancer rod 130. Eachfull trigger 106 stroke moves forward push tube 126 a and pushrod 126 toa length equal to the length travelled by pin 148 b, and advancer rod130 by one increment. The distance between every two adjacent teeth ofratcheted rack 164 is optionally equal to the length of each of anchors112, such that advancer rod 130 pushes forward, with each increment,exactly the length of one anchor.

Trigger 106 optionally has a ratcheted surface 106 a at its upper end,which engages a tooth 106 b biased by a rubber band or spring_106 c(better shown in FIG. 2D, in which shaft blocking lever 140 issemi-transparent) when as the trigger is being pressed. This way, evenif the surgeon ceases to press trigger 106 before completing a fullstroke, the trigger remains in place and does not pop back out; it isheld in place by tooth 106 b. When a full stroke of trigger 106 iscompleted, ratcheted surface 106 a moves forward away from tooth 106 b,and the tooth disengages the ratcheted surface. Trigger 106 is thenreleased, and tooth 106 b slides over ratcheted surface 106 a and allowsthe trigger to assume its original position.

When trigger 106 is released after a full stroke, a spring 146 a thatconnects it to the handle's housing pulls the top part of the triggerdownwards, causing the trigger itself to move forward, to its originalposition. Connecting rod 148 returns backwards and retracts pushrod 126with it, while the backwards retraction of ratcheted rack 164 does notmove advancer rod 130 backwards, despite the fact pin 148 b pushes arear protrusion 164 b of ratcheted rack 164 backwards; the respectivetooth of the ratcheted rack slides over base 130 a and does not move it.A ratcheted bar 130 b affixed to the housing of handle 102 ensures thatbase 130 a cannot move backwards but only forward; a bottom area of base130 a includes a protrusion (not seen in this view) that suitablyengages the ratcheted bar.

The rotation of spool 120 a may be controlled by a cam shaft 162 thatalternates between two positions: one which (a) pushes a top stopper 160upwards and disengages it from a ratchet wheel 120 of spool 120 a and(b) allows a bottom stopper 166 to move upwards and engage the ratchetwheel; and one which does the reverse, and optionally also pushes downthe proximal side of shaft blocking lever 140, such that its distal siderises and unblocks shaft 104 from retracting into handle 102. The secondposition of cam shaft 162 may be selected by the surgeon after pressingthe distal end of shaft 104 onto tissue, and in preparation forretracting the shaft so that needle 108 penetrates the tissue. Inaddition or as an alternative to controlling shaft blocking lever 140from cam shaft 162, it may be controlled by pressing and depressing abutton 168 that directly presses and depresses, respectively, the distalside of the shaft blocking lever.

Each position of cam shaft 162 prevents rotation of spool 120 a in onedirection, and allows its rotation in the opposite direction. Thisallows the surgeon to control the release and retraction of the threadas necessary. Furthermore, the surgeon may utilize a knob 120 b of spool120 a to manually rotate the spool in either direction, if the positionof cam shaft 162 is suitably set.

Optionally, top stopper 160 is flexible so to allow rotation of spool120 a in both directions while making a clicking sound as its edgebounces on the toothed surface of the spool, providing auditory feedbackto the surgeon on the rotation of the spool.

Simultaneously, thread 118 is optionally pulled from its distal freeend, to further aid anchor 112 to reach an approximately perpendicularposture, or at least a posture which places the anchor's central axis at30 degrees or more off the central axis of shaft 104. FIGS. 4A-4C showthis stage (in cross sectional non-cross sectional views), with thedistalmost anchor 112 out of needle 108 and slightly tilted downwards.Pushrod 126 is shown passing through the distalmost aperture 124, andextending to a distance of, for example, 5 to 30 mm from edge 110 ofneedle 108. The pushing of anchor 112 (and the optional pulling ofthread 118) may continue until anchor 112 assumes an approximatelyperpendicular position inside the tissue (this position is not shown inFIGS. 4A-4C).

After successfully deploying the distalmost anchor 112, the advancementmechanism may retract needle 108 into shaft 104 and pushrod 126 intoneedle 108, and the surgeon may move apparatus 100 to a next location inwhich anchor deployment is desired. FIG. 5 shows needle 108 and pushrod126 back in their original locations inside shaft 104, ready to deploythe next one of anchors 112. The surgeon may then reposition the shaft,and repeat operating handle 102, in the manner described above, todeploy the next one of anchors 112. This may be repeated until a desirednumber of anchors 112 has been deployed.

In a hernia defect closure procedure, the anchors may be deployed insuch locations and such order to form a suitable pattern of tissueclosure.

Reference is now made to FIG. 6A, which schematically illustrates threeexemplary anchors 112 that were deployed in the abdominal wall. Asshown, anchors 112 each assume an approximately perpendicular postureinside the tissue. In a hernia defect closure procedure, anchors 112 maybe deployed, for example, into the muscle layer of the abdominal wall,and reside at a depth of, for example, 44 mm to 25 mm inside theabdominal wall, as measured from the fascial direction.

Since thread 118 was threaded through rings 116 when anchors 112 wereinside apparatus 100, they remain threaded therethrough also afterdeployment of the anchors. A distal end of thread 118 is also ejectedfrom apparatus 100, and the two ends 118 a of the thread may be manuallypulled together, which in turn pulls rings 116 and brings anchors 112closer to each other. This is shown in FIG. 6B, in which anchors 112 arecloser to one another, and the two ends of thread 118 are securedtogether using a securing element 132. Alternatively, the two ends ofthread may be simply knotted. The pulling the two ends 118 a of thethread may further contribute to the anchors' 112 movement towards anapproximately perpendicular posture.

As an alternative to pulling together the two ends 118 a of the thread,a locking anchor may be deployed as the first and/or last anchor in theseries. A locking anchor deployed as the first anchor may include aunidirectional or bidirectional locker, that prevents the thread fromsliding unidirectionally or bidirectionally through the anchor. Alocking anchor deployed as the last anchor may include a unidirectionallocker, that allows only a tightening of the suture, e.g., to close thehernia defect. As an alternative to deploying such locking anchors intotissue, they may be only deployed over the thread but not in the tissue,such that their bodies, which are larger than the rings of the otheranchors, are stopped at the rings. They may therefore be referred tosimply as “lockers”.

Reference is now made to FIG. 11A, which shows an exemplaryunidirectional locking anchor. This anchor is structured as a tube,similar to anchor 112 of the previous figures, but has a tooth 220 thatis bent inwardly, into the anchor's lumen. When a thread 202 is threadedthrough this anchor, a free end (not shown) of tooth 200 contacts thethread, and prevents it from moving to the left side of the anchor. Ifthread 202 is pulled to the right, however, it will easily slide overthe free end of tooth 200.

Reference is now made to FIG. 11B, which shows an exemplarybidirectional locking anchor. This anchor utilizes a locking slit 204 toprevent a thread 206 engaged in the slit from moving to eitherdirection. Slit 204 may have a tapered shape, such that, when the leftend of thread 206 is pulled backwards, towards the right end of thethread, the thread gradually enters deeper and deeper into the slit,until reaching very close to its end. There, the tapered shape of slit204 presses on thread 206, slightly compressing it at the contact area,and thus preventing its movement in any direction. Slit 204 isoptionally tapered along its entire length. The tapering is optionallyuniform along the entire length of slit 204, or varies along thislength. Advantageously, if slit 204 is tapered until its very end,thread 206 will tear if pulled with excessive force; the two sides ofthe slit will simply cut deeply into the thread until it rips. Thisserves as a safety mechanism, because the tearing of thread 206 underexcessive tension will prevent the locking anchor from being pulled outof the tissue, severely damaging it.

Those of skill in the art will recognize that various other lockingmeans may be employed at either side of a thread, to prevent the need tomanually form a knot between the two opposing ends of the thread.

Reference is now made to FIGS. 12A and 12B, which show an example ofutilizing a unidirectional locker in a defect 208 closure task. In FIG.12A, four anchors (represented by their rings 212) are deployed intissue in the following order: 212 a, 212 b, 212 c, and 212 d. A locker210 is then positioned over the two ends of a thread 214. Locker 210 isthe slid over thread 214 while pulling the ends of the threads away.This results in the arrangement shown in FIG. 12B, where rings 212 arebrought closer together, defect 208 is closed, and thread 214 is tightlyheld by locker 210.

Reference is now made to FIGS. 13A and 13B, which show another exampleof utilizing a unidirectional locker in a defect 216 closure task. InFIG. 13A, five anchors (represented by their rings 220) are deployed intissue in the following order: 220 a, 220 b, 220 c, 220 d, and 220 e. Athread 222 is optionally tied to the ring 220 a of the first-deployedanchor. Alternatively, a locking anchor may be the first-deployedanchor, such that no tying is required. Further alternatively, a stopper(not shown) may be attached to the end of thread 222 near ring 220 a,such that the thread cannot detach from rings 220 a. This may be, forexample, a T-shaped bar whose leg is attached to the thread, and whosetop shoulders are wider than the diameter of the ring and hence cannotescape it.

After deploying the last anchor, a unidirectional locker 216 ispositioned over the free end of thread 222. Locker 216 is the slid overthread 222 while pulling the end of the thread away. This results in thearrangement shown in FIG. 13B, where rings 220 are brought closertogether, defect 216 is closed, and thread 222 is tightly held by locker216.

Reference is now made to FIGS. 14A-14C, which show a number of exemplarysuturing patterns using the present apparatus. Each of these figuresshows a defect, a suture, and multiple rings of implanted anchors (thatare not shown). FIG. 14A shows a Z-shape pattern, FIG. 14B shows andX-shape pattern, and FIG. 14C shows a purse string pattern.

Reference is now made to FIG. 15, which shows a variant of apparatus100, in which, instead of a single needle housed in a shaft, there is amulti-lumen shaft 250 that houses multiple needles. In this example,there are four lumens 252 a-d that can accommodate four needles (notshown), but a different number of lumens and needles, such as between 2and 8, is explicitly intended herein. A central lumen 254 is alsoprovided, which can contain the loops of the anchors positioned in theneedles in lumens 252 a-d. Each of lumens 252 a-d also accommodates theother components acting together with the needle, such as a pushrod, anadvancer rod, a push tube, etc. (all not shown).

An apparatus with a multi-lumen shaft 250 may contain a relatively largenumber of anchors, so that the apparatus does not need to be extractedfrom the body often to refill anchors or switch to another, full,apparatus.

Reference is now made to FIG. 16, which illustrates how closing a defectwith the present apparatus prevents nerve and/or blood vesselentrapment, compared with standard manual suturing.

At the top left of the figure, two anchors of the present invention areshown implanted in tissue on opposing sides of a defect, and a thread isused to approximate their loops and close the defect.

The bottom left of the figure illustrates a nerve or a blood vessel 304a in tissue 300 a, enclosed between the two anchors and a thread 302 athat connects them. Vessel 304 a stays substantially intact, becausethere is only minimal pressure applied to tissue 300 a by the wires ofthe anchors, and because the thread that connects the rings at the endsof these wires also applies minimal pressure to the tissue.

In contrast, when closing a defect by manual suturing with a surgicalsuture, as shown on the right top and right bottom of the figure, thetightened suture 302 b presses radially on the tissue 300 b are causesdeformation, entrapment, or even closure of a nerve or a blood vessel304 b.

Experimental Results

The inventors have tested an experimental apparatus, which wassubstantially identical to the apparatus disclosed here, on a sacrificedpig. A photograph of the anchor used in the test is shown in FIG. 7.FIGS. 8A-8E, in turn, show photographs of different stages of the test.

A hernia defect was emulated by forming an approximately 40 mm-long tear134′ in the animal's abdominal wall. In FIG. 8A, the shaft 104′ of theexperimental apparatus is shown being pushed against the fascia in afirst location. The free portion of the thread which exits the shaft isshown taught, as it was pulled aside by the tester. FIG. 8B shows theapparatus being pulled back after successful deployment of a firstanchor. The free portion of the thread is now shown at the left side ofthe photo, and the portion that enter the shaft on the right side of thephoto. The ring of the first anchor is shown at 116′.

In FIG. 8C, the apparatus has been repositioned at the next location,now to the right of the tear. A second anchor was deployed at thatlocation. Next (no photograph provided), a third anchor was deployed atthe left side of the tear, at a certain distance from the first anchor.

FIG. 8D, which is a photograph taken at a larger magnification, showsthe thread 118′ extending between the three respective rings 116′ of thedeployed anchors.

FIG. 8E shows the tear closed, after the thread was pulled andtensioned, and the two edges of the tear were brought together by theanchors implanted laterally to the tear. The two edges of the threadwere knotted in a central location between the rings.

Throughout this application, various embodiments of this invention maybe presented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theinvention. Accordingly, the description of a range should be consideredto have specifically disclosed all the possible subranges as well asindividual numerical values within that range. For example, descriptionof a range such as from 1 to 6 should be considered to have specificallydisclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numberswithin that range, for example, 1, 2, 3, 4, 5, and 6. This appliesregardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to includeany cited numeral (fractional or integral) within the indicated range.The phrases “ranging/ranges between” a first indicate number and asecond indicate number and “ranging/ranges from” a first indicate number“to” a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numerals therebetween.

The descriptions of the various embodiments of the present inventionhave been presented for purposes of illustration, but are not intendedto be exhaustive or limited to the embodiments disclosed. Manymodifications and variations will be apparent to those of ordinary skillin the art without departing from the scope and spirit of the describedembodiments. The terminology used herein was chosen to best explain theprinciples of the embodiments, the practical application or technicalimprovement over technologies found in the marketplace, or to enableothers of ordinary skill in the art to understand the embodimentsdisclosed herein.

In the description and claims of the application, each of the words“comprise” “include” and “have”, and forms thereof, are not necessarilylimited to members in a list with which the words may be associated. Inaddition, where there are inconsistencies between this application andany document incorporated by reference, it is hereby intended that thepresent application controls.

What is claimed is:
 1. An apparatus for suturing tissue, comprising: (a)an elongated shaft; (b) a hollow needle disposed inside said elongatedshaft, said needle having: an elongated slit which opens to a distal endof said needle, and an aperture disposed at a distal area of saidneedle; (c) a handle disposed at a proximal end of said elongated shaft;(d) multiple anchors disposed in a single file inside said needle, alongthe length of said needle, wherein each of said multiple anchorscomprises: an elongated tubular body, a loop connected to said tubularbody and exiting said needle through said elongated slit to a spacebetween said needle and an inner wall of said elongated shaft, a finemerging outwardly from said elongated tubular body, wherein a free endof said fin points toward the proximal end of said elongated shaft, andwherein the fin of the most distal anchor in the single file protrudesfrom said needle through said aperture; (e) a thread disposed along thelength of said elongated shaft, in the space between said needle andsaid inner wall of said elongated shaft, and threaded sequentiallythrough said loops of said anchors; and (f) a pushrod disposed in thespace between said needle and said inner wall of said elongated shaft,wherein said pushrod is triggerable by said handle to push the fin ofthe most distal anchor in the single file, thereby to eject the mostdistal anchor in the single file from a distal opening of said needle.2. The apparatus according to claim 1, wherein said loop is a cordemerging from an outer wall of said elongated tubular body, andterminating with a ring.
 3. The apparatus according to claim 1, whereinsaid loop is a rigid wire having a proximal curl secured to said anchor,a straight section, and a distal curl through which said thread isthreaded.
 4. The apparatus according to claim 1, further comprising apush tube disposed inside the elongated shaft and over the needle,wherein the pushrod is attached to a distal end of said push tube, andwherein the triggering of the pushrod is by pushing said push tubedistally.
 5. The apparatus according to claim 4, wherein said handlecomprises a trigger connected to a proximal end of said push tube. 6.The apparatus according to claim 1, wherein said pushrod is flexible andbends when passing through said aperture to push said fin.
 7. Theapparatus according to claim 1, wherein said fin emerges from saidelongated tubular body opposite said loop.
 8. The apparatus according toclaim 1, wherein said handle is configured to allow said elongated shaftto retract into said handle while maintaining said needle stationary, sothat a distal area of said needle is exposed and penetrates tissue. 9.The apparatus according to claim 1, wherein said handle comprises ashaft blocking lever that is movable between a position that blocksbackwards movement of said elongated shaft and a position that allowsbackwards movement of said elongated shaft.
 10. The apparatus accordingto claim 1, wherein said handle comprises a spool of thread.
 11. Theapparatus according to claim 1, wherein said handle comprises a triggerthat is connected to said pushrod.
 12. The apparatus according to claim1, further comprising: a push tube disposed inside the elongated shaftand over the needle, wherein the pushrod is attached to a distal end ofsaid push tube, and wherein the triggering of the pushrod is by pushingsaid push tube distally; and a trigger comprised in said handle, whereinsaid trigger is connected to said push tube, such that depressing saidtrigger pushes said push tube distally.